NCT00297375

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of tramadol HCl/acetaminophen as a pain medication compared with placebo in the treatment of acute pain from a migraine headache. Although tramadol HCl/acetaminophen is approved to treat acute pain, it is not approved for the treatment of acute pain associated with migraine headache. The study hypothesis is that tramadol HCl/acetaminophen is safe and effective as a pain medication in the treatment of acute pain associated with a migraine headache.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
375

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2003

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 28, 2006

Completed
Last Updated

June 10, 2011

Status Verified

April 1, 2010

First QC Date

February 24, 2006

Last Update Submit

June 8, 2011

Conditions

MigraineHead PainHeadache

Keywords

treatmentPainacutemigraineheadache

Outcome Measures

Primary Outcomes (1)

  • Change in baseline headache pain severity at 2 hours post-dose from severe or moderate to mild or none, without using any nausea medication or other pain medication

Secondary Outcomes (1)

  • Pain free at 2, 6 and 24 hrs post-dose; difference in pain intensity and response to therapy over the first 6 hrs post-dose; reduction in occurrence and severity of symptoms; change in functional disability; subject overall rating of change.

Interventions

tramadol HCl/acetaminophenDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with a history of diagnosis of migraine with or without a warning sign (aura), that meets the criteria for a migraine, for at least 1 year
  • History of migraine pain at least moderate in intensity
  • Incidence of 1 to 6 headaches per month in the past year
  • If female, using acceptable method of birth control

You may not qualify if:

  • Patients with routine headaches that could be confused with migraines
  • No more than 13 headache days per month in the past 6 months
  • Onset of migraines after age 50
  • Patients with migraines involving the eyes, chronic migraine or cluster headaches
  • Patients using one or more of the following medications before study entry: more than 1 type of migraine prevention medicine in the past 6 weeks, tramadol within 30 days, vitamins/herbal remedies or non-drug-related remedies for migraine for \< 30 days, St. John's Wort within 30 days, investigational drug in past 30 days or any other disallowed medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Silberstein SD, Freitag FG, Rozen TD, Kudrow DB, Hewitt DJ, Jordan DM, Fisher AC, Rosenthal NR; CAPSS-223 Investigators. Tramadol/acetaminophen for the treatment of acute migraine pain: findings of a randomized, placebo-controlled trial. Headache. 2005 Nov-Dec;45(10):1317-27. doi: 10.1111/j.1526-4610.2005.00264.x.

    PMID: 16324164RESULT

Related Links

MeSH Terms

Conditions

Migraine DisordersHeadachePain

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 24, 2006

First Posted

February 28, 2006

Study Start

April 1, 2003

Study Completion

August 1, 2003

Last Updated

June 10, 2011

Record last verified: 2010-04